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Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

Health Highlights: Nov. 13, 2018

Posted today in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: In-Home Services Coming for Seniors With Private Medicare Advantage Plans In-home services such as help with household chores and caregiver respite will be available to seniors with private Medicare Advantage plans in more than 20 states next year. A health-related reason is needed to qualify, and costs will... Read more

AHA: Physical Activity Guidelines for Americans Updated

Posted today in News for Health Professionals

TUESDAY, Nov. 13, 2018 -- Key guidelines for recommended physical activity in Americans have been updated, according to a special report published online Nov. 12 in the Journal of the American Medical Association to coincide with the annual meeting of the American Heart Association, held from Nov. 10 to 12 in Chicago. Katrina L. Piercy, Ph.D., R.D., from the U.S. Department for Health and Human Services in... Read more

AHA: Limited Benefit for n-3 Fatty Acids in CVD, Cancer Prevention

Posted today in News for Health Professionals

TUESDAY, Nov. 13, 2018 -- Omega-3 fatty acids and vitamin D do not significantly reduce major cardiovascular events or cancer incidence, according to two studies published online Nov. 10 in the New England Journal of Medicine to coincide with the annual meeting of the American Heart Association, held from Nov. 10 to 12 in Chicago. JoAnn E. Manson, M.D., Dr.P.H., from Brigham and Women's Hospital in Boston, and... Read more

AHA: PTSD Common Among Those Who Suffer Tear in the Aorta's Wall

Posted today in Medical

TUESDAY, Nov. 13, 2018 (American Heart Association) -- The sharp and sudden pain from an aortic dissection, along with the emergency treatment that follows, can lead to post-traumatic stress disorder years later, a new study finds. An aortic dissection is a life-threatening condition in which a tear in the wall of the aorta -- the major artery carrying blood out of the heart -- allows blood to rush between the... Read more

18F-FDG PET Algorithm Allows Early Prediction of Alzheimer's

Posted today in News for Health Professionals

TUESDAY, Nov. 13, 2018 -- Fluorine 18 (18F) fluorodeoxyglucose (FDG) positron emission tomography (PET) of the brain can be used to develop a deep learning algorithm for early prediction of Alzheimer's disease (AD) that has high specificity and sensitivity, according to a study published online Nov. 6 in Radiology. Yiming Ding, from the University of California in San Francisco, and colleagues collected prospective... Read more

Denosumab Promising for TDT-Induced Osteoporosis Treatment

Posted today in News for Health Professionals

TUESDAY, Nov. 13, 2018 -- Denosumab (DNM), a fully human monoclonal antibody against the receptor activator of nuclear factor kappa-B ligand (RANKL), may be beneficial for managing transfusion-dependent thalassemia (TDT)-induced osteoporosis, according to a study published online Oct. 31 in Blood Advances. Ersi Voskaridou, M.D., from "Laiko" General Hospital in Athens, Greece, and colleagues randomly assigned... Read more

No Efficacy Signal for Fluoxetine in EV-D68 Acute Flaccid Myelitis

Posted today in News for Health Professionals

TUESDAY, Nov. 13, 2018 -- The antiviral agent fluoxetine is well tolerated but is not effective for patients with proven or presumptive enterovirus D68-associated acute flaccid myelitis (AFM), according to a study published online Nov. 9 in Neurology. Kevin Messacar, M.D., from the University of Colorado School of Medicine in Aurora, and colleagues compared serious adverse events (SAEs), adverse effects, and... Read more

Murder of Family, Friends Takes Highest Toll on Black Teens

Posted today in Medical

TUESDAY, Nov. 13, 2018 -- Teens who lose a family member or friend to murder have an increased risk of suicide, and black teens are most likely to face this kind of heartbreak, a new study finds. University of Pittsburgh researchers analyzed the results of a 2014 survey of just over 1,600 teens, aged 14 to 19, in Allegheny County and found that 13 percent said a friend or family member had been murdered. However,... Read more

Exercise Makes Even the 'Still Overweight' Healthier: Study

Posted today in Medical

TUESDAY, Nov. 13, 2018 -- Heavyset folks who exercise regularly shouldn't get discouraged if they can't seem to shed more weight, no matter how hard they try. A new study suggests that their regular workouts are still contributing to better overall heart health, making them "fat but fit" and helping them live longer. People who are obese-but-fit have lower resting pulse rates, less body fat, higher lean muscle mass... Read more

Heart Failure Patients Shouldn't Stop Meds Even if Condition Improves: Study

Posted today in Medical

TUESDAY, Nov. 13, 2018 -- There's bad news for heart failure patients with dilated cardiomyopathy who'd like to stop taking their meds. Any progress they've seen on medication is likely to fade once they stop taking their heart drugs, new clinical trial results show. About 40 percent of a small group of patients wound up back on their medications after their heart function faltered, said lead researcher Brian... Read more

FDA Approves Yupelri (revefenacin) for Chronic Obstructive Pulmonary Disease (COPD)

Posted 4 days ago in New Drug Approvals

DUBLIN, Ireland, HERTFORDSHIRE, England and PITTSBURGH, Nov. 9, 2018 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma") and Mylan N.V. (NASDAQ: MYL) ("Mylan") today announced that the U.S. Food and Drug Administration (FDA) has approved the  New Drug Application (NDA) for Yupelri (revefenacin) inhalation solution for the maintenance treatment of patients with... Read more

FDA Approves Newly Formulated OTC Primatene Mist (epinephrine) to Treat Mild Asthma

Posted 5 days ago in New Drug Approvals

RANCHO CUCAMONGA, Calif., Nov. 07, 2018 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc., (NASDAQ: AMPH) announced today that the U.S. Food and Drug Administration (FDA) granted approval of its New Drug Application (NDA) for Primatene Mist (epinephrine inhalation aerosol bronchodilator suspension), which is delivered by a metered dose inhaler (MDI) with a non-chlorofluorocarbon (CFC) propellant. Primatene Mist is... Read more

FDA Approves Empliciti (elotuzumab) Plus Pomalidomide and Dexamethasone, a New Immunotherapy Combination for Certain Patients with Relapsed or Refractory Multiple Myeloma

Posted 7 days ago in New Drug Approvals

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Empliciti (elotuzumab) injection for intravenous use in combination with pomalidomide and dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.1 In... Read more

FDA Approves Udenyca (pegfilgrastim-cbqv), a Biosimilar to Neulasta

Posted 10 days ago in New Drug Approvals

REDWOOD CITY, Calif., Nov. 02, 2018 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (NASDAQ: CHRS), today announced that the U.S. Food and Drug Administration (FDA) has approved Udenyca (pegfilgrastim-cbqv), the first pegfilgrastim biosimilar approved by both the FDA and the European Commission (EC) for patients with cancer receiving myelosuppressive chemotherapy. Udenyca is Coherus’ first drug to receive FDA or EC a... Read more

FDA Approves Lorbrena (lorlatinib) for Previously-Treated ALK-Positive Metastatic Non-Small Cell Lung Cancer

Posted 10 days ago in New Drug Approvals

November 2, 2018 Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved Lorbrena [lor-BREN-ah] (lorlatinib), a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) for patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic... Read more

Trevena Receives Complete Response Letter for Oliceridine from FDA

Posted 11 days ago in New Drug Applications

November 2, 2018 -- Trevena, Inc. (NASDAQ: TRVN) today announced the Company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for oliceridine. “While we are disappointed with FDA’s decision, we continue to believe in the strength of the data and the ultimate approvability of oliceridine,” said Carrie L. Bourdow,... Read more

Sage Therapeutics Announces FDA Advisory Committee Votes 17-1 in Support of Benefit-Risk Profile of Zulresso (brexanolone) Injection for Treatment of Postpartum Depression

Posted 11 days ago in New Drug Applications

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 2, 2018-- Sage Therapeutics (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) jointly voted (17 yes,... Read more

Alkermes Reports on Outcome of FDA Advisory Committee Meeting on ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder

Posted 12 days ago in New Drug Applications

DUBLIN, Nov. 1, 2018 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the U.S. Food and Drug Administration (FDA), met to review the company's New Drug Application (NDA) for ALKS 5461. The committee jointly voted that the benefit-risk profile was not adequate to support... Read more

Heron Announces FDA Submission of HTX-011 NDA for Postoperative Pain Management

Posted 13 days ago in New Drug Applications

SAN DIEGO, Oct. 31, 2018 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for HTX-011. HTX-011 is an investigational,... Read more

FDA Grants Priority Review for Sanofi's Dengue Vaccine Candidate

Posted 2 weeks ago in New Drug Applications

BRIDGEWATER, N.J., Oct. 30, 2018 /PRNewswire/ -- The United States Food and Drug Administration (FDA) has accepted a Biologics License Application for Sanofi Pasteur's dengue vaccine. The dengue vaccine candidate has been granted priority review by the FDA as it would represent the first and only medical prevention tool against dengue, including severe dengue, which is considered an unmet medical need. The FDA... Read more

Entasis Therapeutics Announces Zoliflodacin Phase 2 Results Published in The New England Journal of Medicine

Posted 5 days ago in Clinical Trials

WALTHAM, Mass., Nov. 07, 2018 (GLOBE NEWSWIRE) -- Entasis Therapeutics (NASDAQ: ETTX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibacterial products, announced that The New England journal of Medicine (NEJM) published results from a Phase 2 clinical trial evaluating the safety and efficacy of zoliflodacin in patients with uncomplicated gonorrhea. Zoliflodacin... Read more

Janssen Reports Positive Topline Results for FLAIR Phase 3 Study of a Novel, Long Acting Injectable Two-Drug Regimen for the treatment of HIV-1

Posted 12 days ago in Clinical Trials

CORK, IRELAND, October 31, 2018 – The Janssen Pharmaceutical Companies of Johnson & Johnson today confirmed positive topline results from the global, Phase 3 FLAIR (First Long-Acting Injectable Regimen) study of a long-acting, injectable two-drug regimen (2DR) for the treatment of HIV. The study, conducted by ViiV Healthcare, showed long-acting rilpivirine and cabotegravir, injected once a month, had... Read more

Two-year data for Novartis brolucizumab reaffirm superiority versus aflibercept in reducing retinal fluid in patients with nAMD

Posted 2 weeks ago in Clinical Trials

Basel, 27 October, 2018 - Novartis announced additional brolucizumab Phase III results from year two that reaffirmed its positive year one findings. Brolucizumab met its primary endpoint of non-inferiority versus aflibercept in best corrected visual acuity (BCVA) and exhibited superiority in key retinal outcomes at year one (48 weeks)[1],[2]. Secondary endpoints at year two (96 weeks) reaffirmed superiority of... Read more

New STAIRWAY Study Data Shows Potential for Extended Durability With Faricimab in Wet Age-Related Macular Degeneration (AMD)

Posted 2 weeks ago in Clinical Trials

South San Francisco, CA -- October 27, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from the Phase II STAIRWAY study which explored the extended durability of faricimab (RG7716) in the treatment of wet age-related macular degeneration (AMD), a leading cause of blindness in people aged 60 and over in the United States.3 At 52 weeks, faricimab patients... Read more

Biogen and Eisai Announce Presentation of Detailed Analyses from the Phase 1b Long-Term Extension Study of Aducanumab at Clinical Trials on Alzheimer’s Disease (CTAD)

Posted 2 weeks ago in Clinical Trials

CAMBRIDGE, Mass., Oct. 26, 2018 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced that Biogen presented results at the Clinical Trials on Alzheimer’s Disease (CTAD) meeting, in Barcelona, Spain, from the recent 36- and 48-month analyses of the ongoing long-term extension (LTE) of the Phase 1b study of aducanumab, an... Read more